A Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy
Overview[ - collapse ][ - ]
Purpose | The purpose of this study was to evaluate the efficacy, safety, and tolerability of gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of life of all treated patients was also assessed. |
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Condition | Diabetic Neuropathies |
Intervention | Drug: gabapentin |
Phase | Phase 4 |
Sponsor | Pfizer |
Responsible Party | Pfizer |
ClinicalTrials.gov Identifier | NCT00644748 |
First Received | March 25, 2008 |
Last Updated | October 9, 2008 |
Last verified | October 2008 |
Tracking Information[ + expand ][ + ]
First Received Date | March 25, 2008 |
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Last Updated Date | October 9, 2008 |
Start Date | May 2003 |
Estimated Primary Completion Date | August 2004 |
Current Primary Outcome Measures | Change from baseline Mean Pain Score [Time Frame: Endpoint] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy |
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Official Title | An Open, Multicenter Study on the Efficacy, Safety and Tolerability of Gabapentin, Titrated for Reaching an Effect for the Treatment of the Painful Diabetic Neuropathy |
Brief Summary | The purpose of this study was to evaluate the efficacy, safety, and tolerability of gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of life of all treated patients was also assessed. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Diabetic Neuropathies |
Intervention | Drug: gabapentin Gabapentin oral capsules: Week 0: Day 1: 300 mg; Day 2: 600 mg (2 doses of 300 mg); Day 3: 900 mg (3 doses of 300 mg), maintained until the end of the week; After this point, the total daily dose was divided in 3 equal doses. Week 1: Day 1: 1200 mg; Day 2 to 7: 1800 mg Week 2: Day 1: 2100 mg; Day 2 to 7: 2400 mg Week 3: Day 1: 2700 mg; Day 2 to 7: 3600 mg Weeks 4 to 11: 3600 mg |
Study Arm (s) | Experimental: Gabapentin group |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 95 |
Estimated Completion Date | August 2004 |
Estimated Primary Completion Date | Not Provided |
Eligibility Criteria | Inclusion Criteria: - Patients with stable Diabetes Mellitus 1 or 2 - Clinical diagnosis of distal symmetric polyneuropathy with a minimum duration of 8 weeks - No clinically significant motor deficits - Pain described according to at least one of the following clinical manifestations: burning, cramps or twinges, thermal or mechanical alodinea Exclusion Criteria: - Treatment with any medication that may interfere with the assessment of gabapentin during the study or within 7 days of the adminstration of gabapentin - Specific systemic diseases or other medical conditions that would interfere with the assessment of gabapentin therapeutic response or safety |
Gender | Both |
Ages | 51 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Brazil |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00644748 |
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Other Study ID Numbers | A9451004 |
Has Data Monitoring Committee | No |
Information Provided By | Pfizer |
Study Sponsor | Pfizer |
Collaborators | Not Provided |
Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
Verification Date | October 2008 |
Locations[ + expand ][ + ]
Pfizer Investigational Site | Fortaleza, Ceara, Brazil, 60120-021 |
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Pfizer Investigational Site | Taguatinga, DF, Brazil, 72119-900 |
Pfizer Investigational Site | Belo Horizonte, MG, Brazil, 30150-221 |
Pfizer Investigational Site | Curitiba, Parana, Brazil, 80060-150 |
Pfizer Investigational Site | Recife, Pernambuco, Brazil, 52051-380 |
Pfizer Investigational Site | Rio de Janeiro, RJ, Brazil, 20211-340 |
Pfizer Investigational Site | Porto Alegre, RS, Brazil |
Pfizer Investigational Site | Unknown, Sao Paulo, Brazil |
Pfizer Investigational Site | Sao Paulo, SP, Brazil, 01246-903 |
Pfizer Investigational Site | Sao Paulo, SP, Brazil, 04020-041 |